(104 days)
The CRS Fibrin Analysis Catheter Testing System (FACTS) is intended to collect and remove obstructing material from the internal lumen surface of an indwelling central venous catheter to restore or improve catheter flow rate, and to provide a biofilm or fibrin sample which is suitable for microbiological analysis.
The CRS Fibrin Analysis Catheter Testing System (FACTS) is an accessory to peripherally inserted central catheters (PICC). Each single use FACTS kit contains complete instructions for use, 2 pr nitrile powder free gloves (med), 2 each ear loop procedure face masks, 3 each alcohol swabs, 1 each BD Lure-Loc Access Device, 2 each vacutainer tube, 1 each test brush in sheath, 1 each over wrap drape, 1 each measure tape, 1 each clamp and 1 cach specimen transport bag. The testing brush consists of nylon bristles wound onto a flexible stainless steel wire. The testing brush is enclosed within a polysheath that is heat sealed at the distal end and again at the brush handle and is attached by color coded rings. The different rings indicate the diameter of the testing brush bristles.
The provided text is a 510(k) summary for a medical device (CRS Fibrin Analysis Catheter Testing System (FACTS)) but it does not contain details about specific acceptance criteria or a study proving that the device meets those criteria with numerical performance metrics.
The document states:
- "The results of bench and clinical testing indicates that the new device is as safe and effective as the predicate devices." (Page 1)
However, it does not provide any data, acceptance criteria, or study specifics such as:
- A table of acceptance criteria and reported device performance.
- Sample sizes for test sets, data provenance.
- Number/qualifications of experts for ground truth.
- Adjudication methods.
- MRMC comparative effectiveness study results (effect size).
- Standalone algorithm performance.
- Type of ground truth used.
- Sample size for training set or how its ground truth was established.
Therefore, I cannot fulfill the request to describe the acceptance criteria and the study that proves the device meets them based on the provided input. The document is primarily focused on the device's identification, indications for use, description, and its substantial equivalence to predicate devices for regulatory clearance.
§ 880.5970 Percutaneous, implanted, long-term intravascular catheter.
(a)
Identification. A percutaneous, implanted, long-term intravascular catheter is a device that consists of a slender tube and any necessary connecting fittings, such as luer hubs, and accessories that facilitate the placement of the device. The device allows for repeated access to the vascular system for long-term use of 30 days or more, and it is intended for administration of fluids, medications, and nutrients; the sampling of blood; and monitoring blood pressure and temperature. The device may be constructed of metal, rubber, plastic, composite materials, or any combination of these materials and may be of single or multiple lumen design.(b)
Classification. Class II (special controls) Guidance Document: “Guidance on Premarket Notification [510(k)] Submission for Short-Term and Long-Term Intravascular Catheters.”